Short answer is I don't think it will be much diff

Short answer is I don't think it will be much different. Let's do a hypothetical and say CD12 had 2000 participants (BP model). We would only need to show a 22% reduction in deaths to meet our statistical significant p value. Currently at 190, to meet the statistical significance our clinical significance is incredibly high (50% reduction) At this point I would argue (and it has been brought up before ) that the statistical significance has to be balanced by the clinical improvement when determining EUA. I'm no doctor or statistician but it seems pretty obvious to me.